Laparoscopic Surgery of Uterus, Adnex or Ovaries, Postoperative Pain
Conditions
Keywords
acupuncture, anaesthetic recovery, perioperative care, Age 18+, ASA-score ≤ 2, Surgery: Uterus, Surgery: Adnex, Surgery: Ovaries
Brief summary
In the present study, the investigators want to evaluate if press needle acupuncture applied prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve fast-track anaesthesia in the PACU after general surgery.
Detailed description
The use of complementary approaches, especially acupuncture, has gained momentum within the last decade. In this regard, it might be appropriate to develop a simply applicable (a) and effective (b) acupuncture regimen for the complementary support of fast-track anaesthesia. Regarding practicability (a), it might be of interest to reduce the amount of necessary acupuncture points. Trials have shown that single-point acupuncture is strong enough to cause relevant clinical effects (Fleckenstein et al., 2009; Lee and Fan, 2009). In addition, practicability means to reduce the amount of needling events; therefore the investigators suggest the use of press needles, making complete peri-anaesthetic availability possible. Regarding effectiveness (b), it has been reported that acupuncture at Governing Vessel 26 (Du-26) may be successful in shock resuscitation (Hsu et al., 2006). In combination with other points it has been evaluated in a Chinese study improving the vegetative state after operation of acute subdural hematoma (Zheng, 2005).
Interventions
OTHERAcupuncture Regimen
Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press needles (with a sharp tip) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
OTHERAcupressure Regimen
Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press plasters (with a blunt knob instead a sharp needle) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Scheduled for laparoscopic surgery of uterus, adnex or ovaries * ASA-score ≤ 2 * Subjects with the ability to follow study instructions and likely to attend and complete all required visits * Written informed consent of the subject
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery. | The time from extubation to Ready for discharge (in minutes) will followed for the duration in the recovery unit, an expected average of 1 hour | Time from extubation to Ready for discharge (in minutes) from the PACU as assessed by the Aldrete score, the Post Anaesthetic Discharge Scoring System (PADSS) and our 'in-house' scoring system when comparing the acupuncture group and the standard treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Variables | 2 days, ends when anaesthesia starts | Anxiety (STAI-Score) |
| Variables in PACU | Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour | Postoperative pain (pain intensity by VAS) |
| Postoperative variables | Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days | Postoperative pain (pain intensity by VAS) |
| Perioperative Variables | Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours | TCI effect concentrations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 3 days | Occurence of acupuncture side effects |
Countries
Germany
Outcome results
None listed